The correct answer is C, "results of biologic indicators are unavailable prior to use of the item," as this is the primary reason immediate use steam sterilization (IUSS) is not recommended for implantable items requiring immediate use. According to the Certification Board of Infection Control and Epidemiology (CBIC) guidelines, IUSS is a process used for sterilizing items needed urgently when no other sterile options are available, typically involving a shortened cycle (e.g., flash sterilization). However, for implantable items—such as orthopedic hardware or prosthetic devices—ensuring absolute sterility is critical due to the risk of deep infection. Biologic indicators (BIs), which contain highly resistant spores to verify sterilization efficacy, require incubation (typically 24-48 hours) to confirm the kill, but IUSS does not allow time for BI results to be available before the item is used (CBIC Practice Analysis, 2022, Domain III: Infection Prevention and Control, Competency 3.3 - Ensure safe reprocessing of medical equipment). This lack of immediate verification poses a significant infection risk, making IUSS inappropriate for implants, as per AAMI ST79 standards.
Option A (the high temperature may damage the items) is a consideration for some heat-sensitive materials, but modern IUSS cycles are designed to minimize damage, and this is not the primary reason for the restriction on implants. Option B (chemical indicators may not be accurate at high temperatures) is incorrect, as chemical indicators (e.g., color-changing strips) are reliable at high temperatures and serve as an immediate check, though they are not a substitute for BIs. Option D (the length of time is inadequate for the steam to penetrate the pack) is not the main issue, as IUSS cycles are optimized for penetration, though the shortened time may be a secondary concern; the unavailability of BI results remains the decisive factor.
The focus on biologic indicator results aligns with CBIC’s emphasis on ensuring the safety and sterility of reprocessed medical devices, particularly for high-risk implantable items (CBIC Practice Analysis, 2022, Domain III: Infection Prevention and Control, Competency 3.5 - Evaluate the environment for infection risks). This recommendation is supported by AAMI and CDC guidelines, which prioritize BI confirmation for implants to prevent healthcare-associated infections (AAMI ST79:2017, CDC Sterilization Guidelines, 2019).
[References: CBIC Practice Analysis, 2022, Domain III: Infection Prevention and Control, Competencies 3.3 - Ensure safe reprocessing of medical equipment, 3.5 - Evaluate the environment for infection risks. AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2019., , , ]
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